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The Electronic House Call System (Electronic House Call Device + Electronic House Call Application + Electronic House Call Website) is a remote, retrospective monitoring tool for supplement in a patients' care. The Electronic House Call Device together with the Electronic House Call Application is intended to be a simple "store and forward" communications platform that allows clinicians and privileged users to access a patients' information for review through the Electronic House Call Website. The Electronic House Call Device is a tool to monitor patients' remotely and motivate them through education and reminders. The Electronic House Call System allows patients to measure vital signs without assistance from their healthcare provider. The Electronic House Call System is not intended to replace existing treatments or consultations, nor is it to be used as a substitute for a qualified healthcare professional's judgment/treatment plan. The Electronic House Call System is also not intended to act as an emergency response system.

The Express MD Electronic House Call™ System is comprised of a home unit, legally marketed diagnostic peripherals, and a server. The home unit is a communications device that collects data from the diagnostic peripherals and the patient in the home and transmits the data to the server over the home's existing telephone line or other identified method (existing high-speed connection in patients' home). The diagnostic peripherals comprise a wide range of legally marketed medical electronic devices capable of measuring patient parameters such as blood pressure, pulse rate, weight, etc. The server application responds to calls from the home units, collects the data, and then compares the data to preset thresholds. The healthcare practitioners and privileged users access the server through a secure website.

If a patient is found to be outside of a pre-set parameter, the healthcare practitioner will respond according to their set policies. In addition, an email will be sent to the clinician. This email indicates that the nurse/clinician should review the website. This is not a real time alert or an alarm but an email that does not identify a patient, parameter or clinical state.

Here's an analysis of the provided text regarding the Electronic House Call™ System's acceptance criteria and studies:

Analysis based on the provided document (K090801):

The provided 510(k) summary for the "Electronic House Call™ System" is a premarket notification document. For devices of this nature, the focus of the FDA review, and thus the content of the 510(k) submission, is primarily on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing clinical safety and effectiveness through a traditional "study" with detailed performance metrics and acceptance criteria in the way one might expect for a novel therapeutic or diagnostic device.

Therefore, the document does not explicitly define acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic outcome) or provide a detailed study report that "proves" the device meets these criteria. Instead, it relies on demonstrating that the device functions similarly to predicate devices and that core functionalities have been verified and validated.

Here's how to address your points based on the available information:

1. A table of acceptance criteria and the reported device performance:

   Acceptance Criteria (Implicit from Substantial Equivalence and Verification/Validation):

   Acceptance Criterion (Implicit)	Reported Device Performance (Summary from 510(k))
   Functional Equivalence: Device performs core functions like data collection, transmission, and display similar to predicate devices.	The device collects data from diagnostic peripherals, transmits it to a server, displays information, takes vital signs, asks questions, and provides education/reinforcement, similar to predicate devices (Health Buddy, Neptec System, RTX device).
   Data Transmission Reliability: Data is transmitted without affecting safety or effectiveness.	Transmission protocols (telephone line, Cingular 8525 cell phone, high-speed Ethernet) have been validated and "do not affect safety or effectiveness of the device."
   Compatibility with Peripherals: Works with legally marketed diagnostic peripherals.	Compatible with non-invasive blood pressure cuffs, patient weight scales, blood glucose meters, and legally marketed ECG devices using standard digital communication. Verification and validation testing performed.
   Software Functionality: Server application responds to calls, collects data, compares to preset thresholds, and provides secure access to healthcare practitioners.	Server application responds to unit calls, collects data, compares to thresholds. Healthcare practitioners access via a secure website.
   Safety & Effectiveness: Device functions as intended and is safe and effective for its intended use (as a remote, retrospective monitoring tool).	"Verification, validation and electrical safety/electromagnetic compatibility testing was performed to determine that the Electronic House Call™ System functions as intended and is safe and effective for its' intended use."

   Note: The document emphasizes functional equivalency to predicate devices. The "performance" described is about the device's ability to execute its technical functions rather than clinical accuracy or diagnostic performance, as it is a communication platform.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   The 510(k) summary does not provide details on specific sample sizes or data provenance for any "test set" in the context of a clinical study. The "testing" mentioned refers to engineering verification and validation (V&V) and electrical safety/EMC testing. These typically involve testing the device functionalities in a lab or simulated environment, not clinical data sets from patients.

   • Sample Size for Test Set: Not specified, as it's not a clinical study.
   • Data Provenance: Not applicable in the context of clinical data. The V&V would be performed by the manufacturer (Express MD Solutions).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   This information is not applicable or provided. Since there is no clinical "test set" involving patient data and diagnostic outcomes, there's no need for experts to establish ground truth in the traditional sense. The "ground truth" for V&V would be whether the device correctly performs its programmed functions (e.g., correctly transmits data, accurately displays readings from connected peripherals).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   This is not applicable or provided. Adjudication methods are relevant for clinical studies where subjective interpretations or ambiguous cases need a consensus among experts. As explained above, this 510(k) focuses on V&V of a communication system, not diagnostic accuracy.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   No MRMC comparative effectiveness study was done or reported.

   • This device is a "store and forward" communications platform for remote monitoring. It does not incorporate AI for diagnostic interpretation or assist human readers in a diagnostic task in the way an AI algorithm for radiology would.
   • Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this device's function or the claims being made.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   This device is not an "algorithm only" device. It's a system comprised of hardware (home unit, peripherals), software (server application), and a website. Its primary function is communication and data display. While the server application compares data to "preset thresholds," this is a straightforward programmatic comparison, not an "algorithm" in the sense of a complex AI or diagnostic algorithm whose standalone performance needs to be assessed. Therefore, a "standalone algorithm performance" assessment as typically conceived for AI/diagnostic tools was not performed or reported. The "standalone" performance here refers to the system's ability to accurately collect and transmit data from peripherals, which is covered under general V&V.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   For this device, the "ground truth" in its verification and validation is primarily functional correctness and adherence to specifications.

   • Functional Ground Truth: Did the device successfully collect the data? Was the data transmitted accurately? Was it displayed correctly on the website? Did the server correctly identify values outside preset thresholds?
   • This is not "expert consensus, pathology, or outcomes data" as typically used for diagnostic or predictive devices. It's about the technical integrity of the communication and data presentation system.

8. The sample size for the training set:

   Not applicable or provided. This device does not use machine learning or AI models that require a "training set" of data. Its functionality is based on programmed logic and communication protocols.

9. How the ground truth for the training set was established:

   Not applicable or provided. As there is no training set, there's no ground truth for it to be established.

Summary of Device and 510(k) Context:

The Electronic House Call™ System is a telehealth system designed for remote monitoring, acting as a "store and forward" communication platform. Its 510(k) submission successfully demonstrated substantial equivalence to predicate devices primarily through:

• Comparison of technological characteristics: Showing similar components (home unit, peripherals, secure website) and communication methods.
• Verification and validation (V&V) testing: Ensuring the system functions as intended, including data transmission, compatibility with peripherals, and electrical safety/EMC. This V&V is engineering-focused to confirm the device performs its specified technical functions reliably, not a clinical study to assess diagnostic accuracy or clinical outcomes.

The document does not detail acceptance criteria or study results in the manner of a diagnostic device that relies on complex algorithms or clinical interpretation, but rather confirms the technical and functional performance of a communication and data presentation system.

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